Dr John M

cardiac electrophysiologist, cyclist, learner

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The BVS Disappearing Stent: Promise, Hype and the Tension Between Progress and Safety

July 23, 2016 By Dr John

Medicine does not stand still. You want innovation; you want progress. But you also want safety.

Millions of patients have coronary stents placed in the arteries supplying blood to the heart. It’s big business.

Metal cages placed in the setting of a heart attack can be life saving. In other settings, however, the strongest quality evidence says metal cages perform no better than medicines.

One of the two* main reasons stents don’t improve long-term outcomes for patients with stable coronary disease are that they trade improved blood flow (good) for the presence of a metal cage in the artery (bad). The metal cage can stimulate inflammation and cause the artery to lay down more blockage (neo-atherosclerosis). Also, the exposed metal can attract platelets and form clots (really bad).

But what if you could design a stent that dissolved over time? It opens the blockage, improves blood flow, stabilizes the vessel, and then disappears.

This is the promise of Abbott Vascular’s Absorb GT1 bioresorbable vascular scaffold (BVS) system. It’s been used in Europe since 2011 and was just approved by the FDA.

In my most recent column over at theheart.org | Medscape Cardiology, I discuss the tension between progress and safety in regards to the disappearing stent. Central to this issue is understanding hype.

You will soon see direct-to-consumer ads from Abbott Vascular.

Be careful.

In my column, which is written for physicians, I make the case that BVS has great potential–but the actual evidence is dubious. In medical speak, we say the disappearing stent is “non-inferior.” A more neutral look at the evidence suggests it’s closer to inferior.

For instance, the risk of stent failure–sometimes manifested by catastrophic events, such as clotting off abruptly–is 2-3 times greater with the disappearing stent.

The BVS system takes three years to dissolve, so that’s when we’d expect benefits. The problem is we don’t have data that goes that far out; not even close. Yet the FDA advisors easily approved it–some even making glowing remarks.

Another oddity is that the arguably inferior stent will cost more. How is that right?

Finally, make no mistake, this is more than just a debate about a new stent.

The bigger picture is seeing through the fog created when therapeutic optimism, marketing hype and the drive for medical progress mix together.

The title of my column on theheart.org on Medscape is Dissolving Coronary Stents: The Fog of Hype. Here is the intro:

The recent approval by the US Food and Drug Administration (FDA) of the Absorb GT1 bioresorbable vascular scaffold (BVS) system (Abbott Vascular) got me thinking about a modern-day medical problem: the tension between progress and safety.

Precarious is the balance between embracing the new and sticking with the tried and tested—pioneer vs Luddite. Interventional cardiologists are known for their pioneering spirit. By definition, a pioneer takes risks and sometimes suffers consequences.

We allow novel devices leeway because future iterations of a new device often prove beneficial. In general, current-generation drug-eluting stents (DES) perform better than the original versions.[1]

But newer is not always better. The heart rhythm community, including me, in my gullible days, accepted low-profile implantable cardioverter-defibrillator (ICD) leads, such as Medtronic’s Sprint Fidelis. This embrace had disastrous consequences for patients.

Read more…

JMM

* The second reason stents don’t improve long-term outcomes in stable coronary disease is that they are a focal (one spot) answer for a systemic (all-over) disease of atherosclerosis. What’s more, the tightest blockage does not usually cause the heart attack.

Atherosclerosis, or hardening of the arteries, is a disease best treated with all-over things, such as low-inflammation diets, exercise, sleep and fulfilling lives. Oh, and not smoking.

I discuss these concepts in a post about George Bush’s stent procedure. See also… An electrician’s view of smooshing blockages…

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Filed Under: General Cardiology, General Medicine Tagged With: Bioresorbable stent, BVS, Coronary Artery Disease, Coronary stents, Stents

Cycling Wed: I told you so…

November 28, 2012 By Dr John

Dear Endurance Athletes,

More than a year ago, I suggested that Ironman-distance triathlons were not heart healthy. Little did I know that expressing the notion that chronically inflaming oneself might cause permanent heart damage would be so controversial. This post led to my first experience with ad hominem comments. Obviously, talking about the upper limit of exercise is a sensitive matter.

I decided to write this reference-heavy iron-response, and then this follow-up post in the summer.

Today, a WSJ piece stirred the endurance-exercise world with much of the same information previously mentioned here. Now you know it’s real. The WSJ article quoted two soon-to-be published articles in the British journal Heart. I can’t comment on them yet, because they aren’t available. (A little strange.)

But I did find this 18 minute TED-talk given by sports cardiologist, Dr James O’Keefe. Be forewarned…The message might be disturbing to you. Maybe we aren’t born to run?

JMM

Ed note…I liked the reference to Pheidippides. Imagine the inflammation that would have been spared if he had ridden a bike to Marathon?

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Filed Under: Cycling Wed, Exercise, inflammation Tagged With: Coronary Artery Disease, Coronary Calcium Score, Marathon

Only one heart: Treatment of Coronary Artery Disease in the Real World

February 28, 2012 By Dr John

Tonight, I am going to stick up for my interventional cardiology friends. These are the good folks who respond immediately (and I mean immediately) when you have a heart attack. They open clogged arteries. Like Jack Nicholson said, “you want these guys on the wall.”

Why do I feel the need to take up for the apex-predators of Internal Medicine?

Because bio-statisticians and academics are trying to make treating heart disease seem way easier than it really is.

Take this most recent meta-analysis (Archives of Internal Medicine) of stents versus medical therapy in patients with “stable” coronary disease. The researchers pooled multiple previous trials where stents and meds were compared and found no difference in outcomes. (Detailed summaries are available on TheHeart.org and Cardiobrief.) It’s not intuitive to think that stenting open an artery (sometimes from 90% to 0%) does not reduce the chance of death, future heart attack, or unplanned heart surgery. But this data looks very real.

Adding to the piling-on effect was an invited editorial from Dr William Boden, the lead author of the Courage Trial, which just so happens to be the ‘landmark’ study of meds versus stents. In 2007, in the NEJM, Courage investigators concluded “PCI [stents] did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.” Asking Dr Boden how he feels about this meta-analysis is like asking me if the double Ironman is dumb. Of course, Dr Boden thinks treating blockages with stents is overrated.

Let’s insert a real world view:

The reality here is that treating major blockages in the heart (as if there were such things as minor blockages) with only medicines constitutes very aggressive and risky behavior.

Consider these common scenarios:

A patient presents to the emergency room with atypical, fleeting and clearly non-heart-related chest pain. Or perhaps a marathoner wants a stress test; or a diabetic patient needs pre-op clearance.

Unless a patient’s risk of heart disease approaches zero, a rarity, they get referred for further testing, which means looking for blockages. Remember, there is no room for being wrong–none. Perfection. Never be wrong.

So, the patient comes for a stress test. “Ma’am, we are doing this test to look for blockages.”

Alas, the stress ECG looks a little funny. Suspicions arise. Never comes up again; never be wrong.

“Ma’am, your stress test is positive…I think you should have a cath…This is a test where we look for blockages in the heart’s arteries.”

Heart doctors usually recommend looking for blockages after positive stress tests because untreated major blockages may lead to bad outcomes, like death.

The consternation starts when the cath shows an 80% blockage. Before the meta-analysis and trials named Courage, a heart doctor would squish and stent the blockage and render the artery 100% clear, or 0% blocked. That part of the heart gets more blood; the patient feels fixed; the doctor declares victory.

Both the general public and the majority of the medical world view this scenario as ‘normal.’ The story is told in doctors’ lounges, on golf courses and even on bike rides. “My heart doctor fixed my blockage.”

What the public doesn’t know is that 80% blockages aren’t often the ones that will cause the future heart attack. Rather, heart attacks come from the 10% blockage that gets nary a mention, or is called a minor blockage.

Back to medical therapy: the reason why lowering cholesterol with statins, treating high blood pressure, using adrenaline (beta)-blockers and instituting lifestyle changes can produce equal outcomes to stents is that such measures target the disease of atherosclerosis at its root, whereas stents just fix the end-result.

Ah…But here is where real life makes it tough to implement such an academic strategy. It’s very hard to walk away from an 80% blockage. What do you tell your patient if she wants to run, or play tennis? What about the next time someone cuts her off in traffic and adrenaline levels surge? What if it was your left anterior descending artery—you know, the “widow-maker” artery? Finally, imagine explaining to the primary care doctor that it was a good idea to leave the artery 80% blocked? I’m not sure about how things roll in Boston and Hanover, but this would be a tough sell in Kentucky.

My eye-surgeon friend said it well when she noted how stressful it would be to work on the heart. Why? I asked. “Because people have two eyes but only one heart.”

Conclusion:

I’m putting my money down that aggressive targeting of atherosclerosis, not just with pills, but strict attention to diet, exercise and behavior modification, could indeed equal stenting. But there are a lot of unknowns with this strategy:

Will the US ever accept a healthcare system that allows doctors not to exclude everything possible? Maybe then we could stop doing so many stress tests and caths?

Will heart patients ever be expected to help themselves? Could a recommendation to stop smoking, eat less, exercise more and take a few basic medications be considered adequate medical treatment for a blockage? Or will such advice continue to be labeled as mean, unfeeling and not doing everything?

And here’s a biggie question:

How many of the 23 authors of Courage would accept medical therapy of their 80% blockage once they saw it?

JMM

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Filed Under: General Cardiology, Healthy Living Tagged With: Coronary Artery Disease, Coronary Heart disease, Coronary stents, Stents

John Mandrola, MD

Welcome, Enjoy, Interact. john-mandrola I am a cardiac electrophysiologist practicing in Louisville KY. I am also a husband to a palliative care doctor, a father, a bike racer, and a regular columnist at theHeart.org | Medscape

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